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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041160
Receipt No. R000047000
Scientific Title Evaluation study of preventing exacerbations for home care patients with chronic diseases by using dual-monitoring-based telenursing system-a prospective longitudinal mixed methods study
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/20

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Basic information
Public title Evaluation study of preventing exacerbations for home care patients with chronic diseases by using dual-monitoring-based telenursing system-a prospective longitudinal mixed methods study
Acronym Evaluation study of preventing exacerbations for home care patients by using dual-monitoring-based telenursing system-a prospective longitudinal mixed methods study
Scientific Title Evaluation study of preventing exacerbations for home care patients with chronic diseases by using dual-monitoring-based telenursing system-a prospective longitudinal mixed methods study
Scientific Title:Acronym Evaluation study of preventing exacerbations for home care patients by using dual-monitoring-based telenursing system-a prospective longitudinal mixed methods study
Region
Japan

Condition
Condition COPD, IPF, Post-aspiration pneumonia, Diabetes, Amyotrophic lateral sclerosis, Congestive heat failure, Lung cancer, COVID-19
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether providing three months of dual-monitoring telenursing is useful for preventing acute exacerbations and improving participants' health outcomes by using a prospective longitudinal mixed methods study approach.
Basic objectives2 Others
Basic objectives -Others To evaluate whether providing three months of dual-monitoring-based telenursing is useful for preventing acute exacerbations and health outcomes for people with COPD, IPF, Post- aspiration pneumonia, DM, ALS, CHF, Lung Ca and COVID-19 positive by using longitudinal mixed methods study approach.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Acute exabertions
Key secondary outcomes Self-care, health literacy, adherance, daily living status, ALD, self-management, self-efficacy, quality of life, feeling of safety, satisfactions, depression, daily monitoring status, disease stability, prescriptions and health-care fee.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Using a telenursing system
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.COPD: Patients who receive home oxygen therapy according to stage IV chronic obstructive pulmonary disease. Includes users of non-invasive positive pressure ventilation.2.IPF: Patients with interstitial pneumonia diagnosed by Severity classification I to IV of idiopathic pulmonary fibrosis.
3.AP: A person who is diagnosed with aspiration pneumonia and starts home care after hospitalization.4.DM: Patients with diabetes stage 4 diabetic nephropathy third stage who need blood sugar/blood pressure control.5. ALS: A person who is able to visit an outpatient with a severity classification of 4 degrees or less by the Ministry of Health.6.HF: Those who is NYHA classification II-III of chronic heart failure due to angina, coronary artery disease, valvular disease, cardiomyopathy, etc.7.Lung ca: Those receiving cancer drug therapy due to lung cancer. 8.COVID-19 positive.
Target selection criteria (1) Those who regularly visit the outpatient clinic and continue to receive medical treatment.(2)Those who can obtain the consent of the attending physician to participate in this study.(3)A person who can secure a place to install a tablet terminal and a set of measuring equipment in the target person's home.(4)Those who have no hindrance to cognitive function, have alternatives to limb functions, can self-measure daily blood pressure, oxygen saturation, etc., and can answer questions, and understand terminal operations.(5)Those who can use the long-term care insurance service, social resources, etc. regardless of the usage status, even during the research cooperation period.(6)Age 65 years old or older (However, only ALS must be aged 60 years old or older).
Key exclusion criteria Exclusion criteria will be:
1. Those who are in the end-stage status
2. Those who are in a state of serious depression
3. A person who has a decline in cognitive functions or a decline in limb function and cannot obtain assistance in operating the telenursing devices.
4.Those who need hospital treatment
Target sample size 42

Research contact person
Name of lead principal investigator
1st name Tomoko
Middle name
Last name Kamei
Organization St. Luke's International University Graduate School
Division name Graduate School of Nursing Science
Zip code 1040044
Address 10-1 Akashi-cho, Chuo-ku, Tokyo
TEL 03-5550-2283
Email kamei@slcn.ac.jp

Public contact
Name of contact person
1st name Tomoko
Middle name
Last name Kamei
Organization St. Luke's International University Graduate School
Division name Graduate School of Nursing Science
Zip code 1040044
Address 10-1 Akashi-cho, Chuo-ku, Tokyo
TEL 03-5550-2283
Homepage URL
Email kamei@slcn.ac.jp

Sponsor
Institute St. Luke's International University Graduate School
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Healthcare University, Tokyo Metropolitan Institute of Medical Science, Hamamatsu University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization St. Luke's International University Research Administration Office
Address 10-1 Akashi-cho, Chuo-ku, Tokyo
Tel 03-5550-2423
Email kenkyukikaku@luke.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 27 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 20 Day
Last modified on
2020 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047000

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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